1. Field of the Invention:
A one piece tube and microscope slide manipulative laboratory device for use in clinical procedures, and particularly the labor intensive clinical procedure of urinalysis. Urinalysis technique minimally requires that a urine specimen be first tested for specific gravity, which is an important indicator of kidney function and the regulation of electrolyte concentration in patients receiving intravenous fluid therapies. Secondly, urinalysis requires the analysis of any sediment which may be present in the urine, since sediment is an indication of various pathologies in the patient, and the urine sediment is necessarily prepared in a slide for placement under a microscope objective. The present invention, therefore, is a one piece tube and microscope slide manipulative laboratory device which is a one tube system for both measuring specific gravity and performing a microscopic examination, without the need for such labor-intensive operations as a separate decanting of the sediment from the specimen after it has been centrifuged to collect the sediment.
2. Description of the Prior Art
A search of prior art patents concerned with manipulative laboratory devices for use in clinical procedures employing a test specimen, and particularly clinical procedures involving urinalysis, has developed the U.S. Pat. Nos., as follows: WEICHELSBAUM 2,664,403,
Natelson 2,685,800, PA1 Adams 3,415,361, PA1 Shaw 3,460,395, PA1 Foderick 3,543,743, PA1 Reid 3,641,825, PA1 Erickson 3,642,450, PA1 Price 3,666,421, PA1 Smith 3,682,321, PA1 Clarke 3,705,011, PA1 Speck 3,753,863, PA1 Seidler 3,774,455, PA1 Bauer 3,811,840, PA1 Von behrens 3,914,985, PA1 Yee 3,955,928.
There is not found in the prior art a one-tube device which allows for a specific gravity, or chemical, examination as an initial step, with the automatic preparation of microscopic slide as the result of a subsequent centrifugation. None of the above-noted patents disclose a one-tube system for urinalysis, wherein a separable microscopic slide is filled with urine sediment, simultaneously with a centrifugation of the entire device.
The patent to Seidler illustrates a urine testing apparatus, though one that requires a separate decanting of urine in order to remove sediment for further analysis, for example, in the lid shown in FIG. 5. Seidler also shows the use of a cap, 31, at FIG. 6, but his cap requires a manual filling with sediment, and does not function as a microscopic slide for immediate microscopic analysis of collected sediment.
The patent to Von Behrens illustrates a centrifugation device specifically illustrated for use with blood serum analysis, though with mention that it may be useful for other biological fluids, such as urine. Von Behrens also employs a contruction having multiple parts, wherein a separable inner capillary, 13, is cushioned by a fluid contained within a outer tube 11. In the embodiment of FIG. 6, as explained at col. 8, lines 25 et seq., when the device is intended to be used for urine, for example, the closed-up capillary tube, 13, as shown in FIG. 6, is preferred. However, use of the device taught by Von Behrens requires both an initial centrifugation, and a subsequent high speed centrifugation. Furthermore, the capillary tube 13 is neither structurally nor functionally equivalent to a preformed planar microscopic slide. The other abovelisted patents are considered less pertinent that either Seidler or Von Behrens, and are noted primarily to illustrate various known constructional features of manipulative laboratory devices.
Bauer illustrates a disposable specimen testing device, wherein a wick which is contained in a substantially flat surface portion of a fluid impervious sheath, having an aperture therethrough. This, then, is a "dip and read" device, which is significantly characterized by the addition of a wick structure, and is merely illustrative of a slide-type of testing device.
The patents to Reid, Foderick, and Shaw illustrate various types of urinometers, wherein a container is structured to allow for measuring the specific gravity of a urine sample volume. Of course, these devices are adapted only for performing a specific gravity measurement function, and do not also allow for a single-tube development of a microscopic slide, upon a subsequent centrifugation.
The patents to Ericksson, Price, and Adams illustrate manipulative laboratory devices characterized by unitary containers for allowing specific reagents to mix with a biological fluid. As such, these three devices merely illustrate prepackaged laboratory devices. The patent to Price particularly illustrates a test slide which is both disposable and inclusive of quantities of test reagents. The patent to Adams similarly requires application of aliquots of a fluid to be tested, and at FIG. 1 illustrates a cap, integrally formed with the main body of a vessel, and hinged by a notched bridge, at 36.
The patents to Weichelsbaum and Natelson are noted to illustrate manipulative laboratory devices that are frangible, at a particular cross-sectional area. As such, they simply illustrate known techniques for insuring a frangible connection in a laboratory device.
The patent to Smith illustrates a plastic filter assembly, which allows for certain urine analysis procedures without the necessity for centrifuging. As such, it is noted primarily to illustrate yet another approach to a disposable urinalysis device. Similarly, the patents to Clark, Speck, and Yee illustrate urinalysis techniques, and particularly techniques wherein a urine sample is ultimately evaluated by an optical density determination. These patents are noted merely to illustrate particular chemical reagent mixing techniques in the art of urinalysis, wherein conventional test tubes are used as the specimen container.
In summary, no prior patent is known which teaches a one-tube assembly specifically adapted for urinalysis, and one characterized by a test tube type reservoir having an optically clear plastic microscopic slide frangibly connected to its lower extremity.